The Ministry of Food and Drug Safety announced on the 11th that it has referred a company and its representative to prosecutors for violating the Medical Devices Act by importing and selling a 'plasma electric surgical device' that was not approved as a medical device.
The plasma electric surgical device, commonly referred to as a mole and fibroma remover, must receive Class 3 medical device approval to be released and sold in Korea. However, the company sold it illegally as a beauty device without obtaining approval.
According to the investigation, the suspect imported 115 mole and fibroma remover devices from Germany between September 2020 and February this year and confirmed that they were sold in full as beauty devices without medical device approval. The total amounts to approximately 900 million won.
They conducted seminars and used social networking service (SNS) advertisements to demonstrate and educate on the removal technique directly to skin care professionals. To avoid crackdowns, they instructed buyers to use alternative terms such as 'tag out' instead of 'mole and fibroma removal.'
Cases of side effects such as inflammation, scarring, and skin discoloration resulting from procedures using the product have also been confirmed.
The Ministry of Food and Drug Safety urged that when removing moles and fibromas using unapproved medical devices in skin care facilities, side effects such as inflammation and skin discoloration may occur, and that individuals should consult with physicians or other experts to choose the proper treatment method. They also noted that they will actively crack down on and impose strict penalties for the import and sale of unapproved medical devices in the future.